Externally worn transceiver for use with an implantable medical device

ABSTRACT

An implantable medical device system that includes an implantable medical device, along with a transceiver device that exchanges data with the patient, between the patient and the implantable medical device, and between a remote location and the implantable medical device. A communication device coupled to the transceiver device exchanges data with the transceiver device, the implantable medical device through the receiver device, and between the transceiver device and the remote location to enable bi-directional data transfer between the patient, the implantable medical device, the transceiver device, and the remote location. A converter unit converts transmission of the data from a first telemetry format to a second telemetry format, and a user interface enables information to be exchanged between the transceiver device and the patient, between the implantable medical device and the patient through the transceiver device, and between the patient and the remote location through the transceiver device.

RELATED APPLICATIONS

This application claims priority and other benefits from U.S.Provisional Patent Application Serial No. 60/243,612, filed Oct. 26,2000, entitled “EXTERNALLY WORN TRANSPONDER/SENSOR FOR USE WITH ANIMPLANTABLE MEDICAL DEVICE”

FIELD OF THE INVENTION

The present invention generally relates to implantable medical devicesand communication therewith, and in particular, the present inventionrelates to a transceiver device in proximity to the implantable medicaldevice and an external sensor that cooperates with the implantablemedical device to produce a desired therapy in one or more implantablemedical devices.

BACKGROUND OF THE INVENTION

Various medical devices have been developed that acquire informationfrom one or more physiologic sensors or transducers. A typicalphysiologic sensor transduces a measurable parameter of the human body,such as blood pressure, electrical activity (ECG), temperature or oxygensaturation, for example, into corresponding electrical signals. In manyimplantable medical device applications, it is often desirable ornecessary to acquire physiological data for extended periods of time andon a continuous basis. In addition to the continuous acquisition ofphysiological data, there are many applications in which it is oftendesirable to implement a patient diary of sorts by enabling the patientto input relevant information at appropriate times so that the combinedcontinuous data acquisition and patient input provides a record that canbe used to better understand other physiologic events or to createsignals.

A problem well known to designers of implantable medical devices, suchas pacemakers, for example, concerns the necessity of using low powercomponents, including low power memory and processing components, withinthe implantable medical device. Use of low powered components isconsidered necessary in order to provide for extended periods ofimplantable medical device operation, and to reduce the need torepeatedly replace batteries, which can only be accomplished throughsurgical means. As a consequence, conventional implantable medicaldevices typically employ low voltage, low current memory and processingdevices, which have limited storage capacity and access speed, and oftenlag behind the state-of-the-art memory and processing technology byseveral years. These and other limitations significantly decrease thedata storage, processing power, and access capability of implantablemedical devices, and often precludes the opportunity to integrate highcapacity, low cost, state-of-the-art memory and processing devices inimplantable medical device designs.

Various implementations of portable or user-worn electrocardiographicrecording/monitoring devices are known in the art, examples of which maybe found in the issued patents list in Table 1 below.

TABLE 1 U.S. Pat. No. Inventor(s) Issue Date 6,200,265 Walsh et al. Mar.13, 2001 5,833,603 Kovacs et al. Nov. 10, 1998 5,721,783 Anderson Feb.24,1998 5,720,770 Nappholz et al. Feb. 24, 1998 5,759,199 Snell et al.Jun. 2, 1998 5,634,468 Platt et al. Jun. 3, 1997 5,511,553 SegalowitzApr. 30, 1996 5,289,824 Mills et al. Mar. 1, 1994 5,191,891 Righter Mar.9, 1993 5,113,869 Nappholz et al. May 19, 1992 4,660,568 Cosman Apr. 28,1987 4,622,979 Katchis et al. Nov. 18, 1986 4,494,950 Fischell Jan. 22,1985

Conventional portable or patient-worn electrocardiographic (ECG)monitor/recorders, such as those disclosed in one or more of the patentslisted in Table 1 above, are autonomous systems that enable only limitedinteraction between the patient and the device, and can only be used inaccordance with a single specific telemetry format. Accordingly, what isneeded is a device for communicating with an implantable medical devicethat allows increased patient interaction with the device, seamlesstransmission of data to other devices, including an Internet appliance,a cellular network, and so forth, enabling use across multiple telemetryformats and between multiple implantable medical devices to store andmanage information from a broad range of devices.

SUMMARY OF THE INVENTION

The present invention relates to an implantable medical device systemthat includes an implantable medical device for implantation within apatient that monitors physiologic conditions of the patient and/ordelivers a therapy in response to physiologic conditions. A transceiverdevice coupled to the implantable medical device along a wireless linkexchanges data with the patient, between the patient and the implantablemedical device, and between a remote location and the implantablemedical device. A communication device coupled to the transceiver devicealong a wireless link exchanges data with the transceiver device andwith the implantable medical device through the transceiver device, andexchanges data between the transceiver device and the remote location.In this way, the implantable medical device system enablesbi-directional data transfer between the patient, the implantablemedical device, the transceiver device, the communication device, andthe remote location.

According to a preferred embodiment of the present invention, a patientwearable transceiver device exchanges data with an implantable medicaldevice for implantation within a patient. The transceiver deviceincludes means for receiving information from the implantable medicaldevice, means for exchanging data between the patient, the implantablemedical device, the communication device, and a remote location, andmeans for processing the data exchanged. The means for receiving, themeans for exchanging, and the means for processing enable bi-directionaldata transfer between the patient, the implantable medical device, thetransceiver device, and the remote location.

Another aspect of the present invention includes a converter unit thatconverts transmission of the data between the implantable medicaldevice, the transceiver device, and the communication device from afirst telemetry format to a second telemetry format.

In yet another aspect of the present invention, an implantable medicaldevice system includes an implantable medical device for implantationwithin a patient that monitors physiologic conditions of the patient,and/or delivers a therapy in response to the physiologic conditions,along with a transceiver device coupled to the implantable medicaldevice along a wireless link that exchanges data with the patient,between the patient and the implantable medical device, and between aremote location and the implantable medical device. A communicationdevice coupled along a wireless link to the transceiver device exchangesdata with the transceiver device and with the implantable medical devicethrough the transceiver device, and exchanges data between thetransceiver device and the remote location. A converter unit convertstransmission of the data between the implantable medical device, thetransceiver device, and the communication device from a first telemetryformat to a second telemetry format, and a direct interface couples thetransceiver device to an external device to enable direct downloading ofthe data and configuration/setup information to the external device, andconnection to user interface devices. An external reference sensorsenses a parameter external to the patient, and the transceiver devicereceives the sensed parameter from the external reference sensor and/orreceives data from the implantable medical device. A user interfaceenables information to be exchanged between the transceiver device andthe patient, between the implantable medical device and the patientthrough the transceiver device, and between the patient and the remotelocation.

According to yet another aspect of the present invention, the userinterface includes a patient physiologic parameter portion that displaysthe physiologic conditions of the patient, a daily activity diaryportion that enables the patient to input activities to the transceiverdevice, and a medication reminder portion that displays medicationreminders in response to a request received from the implantable medicaldevice and in response to data processed by the implantable medicaldevice and the transceiver device. An event storage portion storesinformation, including the input activities and the physiologic signalsassociated with the patient, processes the information, and acquireshigh resolution activity in response to the information. A send messageportion stores messages transmitted between the remote location and thetransceiver device and/or the patient, and a status portion adjusts anddisplays battery status, therapy status, and settings of the transceiverdevice. Finally, a receive message portion of the interface receivesmessages transmitted between the remote location and the transceiverdevice and/or the patient, including automated information, adjustingparameters and output of the implantable medical device, along withmanual information, input directly at the transceiver device.

According to yet another aspect of the present invention, the datareceived by transceiver device is used as feedback control informationfor a second implantable medical device for implantation within thepatient.

According to another aspect of the present invention, a removable memorystores information received directly from the transceiver device andreceived from the implantable medical device through the transceiverdevice.

According to another aspect of the present invention, the transceiverdevice triggers the implantable medical device to change from a normalstate, in which implantable medical device gathers data at a first rateand performs a relatively high amount of averaging, to a second state inwhich the amount and resolution of data is increased so that anincreased resolution of data is obtained and stored in transceiverdevice in response to an input to the transceiver by the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention which are believed to be novel areset forth with particularity in the appended claims. The invention,together with further objects and advantages thereof, may best beunderstood by making reference to the following description, taken inconjunction with the accompanying drawings, in the several figures ofwhich like reference numerals identify like elements, and wherein:

FIG. 1 is a schematic view of an implantable medical device systemaccording to the present invention.

FIG. 2 is a schematic diagram of a transceiver device of the implantablemedical device system of FIG. 1 according to the present invention.

FIG. 3 is a schematic diagram of multi-directional data transmissionusing a transceiver device of the implantable medical device system ofFIG. 1.

FIG. 4 is a schematic diagram of a user interface of a transceiverdevice of the implantable medical device system of FIG. 1.

FIG. 5 is a schematic diagram of remote processing of an implantablemedical device according to the present invention.

FIG. 6 is a schematic diagram of multi-directional data transmissionusing a transceiver device of the implantable medical device system ofFIG. 1.

FIG. 7 is a schematic diagram of multi-directional data transmissionusing a transceiver device in the implantable medical device system ofFIG. 1.

FIG. 8 is a schematic diagram of multi-directional data transmissionusing a transceiver device in the implantable medical device system ofFIG. 1.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

FIG. 1 is a schematic view of an implantable medical device systemaccording to the present invention. As illustrated in FIG. 1, animplantable medical device system 100 according to the present inventionincludes an implantable medical device 102 implanted within a patient104 for delivering a therapy in response to physiological conditions ofpatient 104, or for monitoring conditions of patient 104. Implantablemedical device 102 may be an implantable cardiac pacemaker, such asthose disclosed, for example, in U.S. Pat. No. 5,158,078 to Bennett etal., U.S. Pat. No. 5,312,453 to Shelton et al., or U.S. Pat. No.5,144,949 to Olson, hereby incorporated herein by reference in theirrespective entireties. Implantable medical device 102 may also be apacemaker/cardioverter/defibrillator (PCD), such as those disclosed, forexample, in U.S. Pat. No. 5,545,186 to Olson et al., U.S. Pat. No.5,354,316 to Keimel, U.S. Pat. No. 5,314,430 to Bardy, U.S. Pat. No.5,131,388 to Pless, or U.S. Pat. No. 4,821,723 to Baker et al., allhereby incorporated herein by reference in their respective entireties.

Alternately, implantable medical device 102 may be an implantable nervestimulator or muscle stimulator, such as those disclosed in U.S. Pat.No. 5,199,428 to Obel et al., U.S. Pat. No. 5,207,218 to Carpentier etal., or U.S. Pat. No. 5,330,507 to Schwartz, or an implantablemonitoring device, such as the device described in U.S. Pat. No.5,331,966 issued to Bennet et al., all of which are hereby incorporatedherein by reference in their respective entireties. By way of furtherexample, implantable medical device 102 may be an implantable nervestimulator or muscle stimulator, such as those disclosed in U.S. Pat.No. 5,199,428 to Obel et al., U.S. Pat. No. 5,207,218 to Carpentier etal., or U.S. Pat. No. 5,330,507 to Schwartz, or an implantablemonitoring device, such as that disclosed in U.S. Pat. No. 5,331,966issued to Bennet et al., all of which are hereby incorporated herein byreference in their respective entireties. Implantable medical device 102may also be an implantable blood oxygen sensing monitor or animplantable hemodynamic monitor.

According to the present invention, implantable medical device 102monitors any number, combination or type of parameters, such as oxygen,pressure, cardiac flow, stroke volume, cardiac EGM, cardiacacceleration, etc. While implantable medical device 102 has beendescribed as being one of the above-referenced devices, it is understoodthat the present invention is applicable in any form of implantablemedical device requiring storage of appreciable amounts of physiologic,diagnostic, system, or other data, particularly those that acquireinformation on a continuous or near continuous basis.

In addition, according to the present invention, a transceiver device106, such as a pager, band-aid, wristwatch, or pendant type device, isworn by, attached to, or positioned within close proximity to patient104 in order to be bi-directionally coupled to implantable medicaldevice 102 along a wireless telemetry link 108. Telemetry link 108 willbe dependent upon the type of implantable medical device utilized. Forexample, in a medium range system, telemetry link 108 will typicallyrange from approximately 0.1 to 1.0 meters.

Transceiver device 106 is also coupled, along a wireless link 110, suchas a RF (UHF) link or an infrared (Ir) link, for example, to acommunication device 112, located near or within the patient's home.According to the present invention, communication device 112 includes abase station, a monitor, a physician programmer, or other similar deviceand is connected to the Internet 120 through a transmission medium 118,such as a modem, cell phone, or Ethernet, etc. In this way, transceiverdevice 106 exchanges data with a remotely located applications and datastorage unit 114, or a remotely located health care provider 116 throughtransmission medium 118.

Link 110 will be dependent upon the transmission limitations designedfor transceiver device 106 and communication device 112, and in apreferred embodiment of the present invention ranges from approximately1.0 to 100 meters, for example. An additional input or sensor 122 inputsinformation external to patient 104, such as barometric pressure,temperature, patient body position, and patient posture, for example, tocommunication device 112. In this way, by enabling bi-directionaltransmission of data between implantable medical device 102 and remotelocations, such as data storage unit 114 or health care provider 116,for example, and between patient 104 and implantable medical device 102,the present invention enables a more seamless method for controllingtherapy associated with implantable medical device 102, transmittingdata physiologic data remotely back to the physician, in real time,closing a loop between multiple implantable devices, and providingadditional processing power in order to perform algorithms externallyfrom implantable medical device 102, as will be described below.

FIG. 2 is a schematic diagram of a transceiver device of the implantablemedical device system of FIG. 1 according to the present invention. Asillustrated in FIG. 2, transceiver device 106 includes a medium rangetelemetry unit 130 for enabling bi-directional transmission of databetween transceiver device 106 and implantable medical device 102. Inaddition, in situations where a second implantable medical device 132 islocated within patient 104, transceiver device 106 of the presentinvention performs bi-directional data transmission with either one orboth of implantable medical devices 102 and 132. An environmental sensorunit 134 includes sensors for determining environmental conditions suchas body position of patient 104, temperature, or barometric pressure. Amemory unit 136 is utilized to store code and algorithms, in addition todata and usage storage log and directories. A transceiver unit 138enables the transmission of data between transceiver device 106 andcommunication device 112 for seamless transmission to remote locationsover the Internet. A removable memory 140, such as a PG card, etc.,located within transceiver device 106 enables information receivedeither directly from transceiver device 106 or from implantable medicaldevice 102 through transceiver device 106 to be stored thereon. Once theinformation is stored, removable memory 140 may then be removed fromtransceiver device 106 and transferred by patient 104 to a physician orother medical personnel, such as when patient 104 does not have Internetconnectivity, for example.

According to the present invention, patient 104 inputs information totransceiver device 106 through buttons, keys. etc., located at a userinterface 142 of transceiver device 106. In addition, user interface 142includes a display, LEDs and so forth, along with one or more alarms andspeakers, for example, to enable information to be transmitted directlyfrom transceiver device 106 to patient 104, or from implantable medicaldevice 102 to patient 104 through transceiver device 106, and to enablea manual or automated message to be transmitted from the remote location114 and 116 to the patient. A direct interface 144, such as an infraredport, a serial port, or a universal serial bus connects transceiverdevice 106 to an external device, such as a laptop, for example, toenable direct downloading of data, configuration/setup information,connection to user interlace devices, and so forth. A power source 146,including one or more rechargeable batteries for example, along withrecharge circuitry to power transceiver device 106, is included withintransceiver device 106, along with a clock 148, which time stamps alldata flowing within transceiver device 106 to correlate when certainevents are taking place. A GPS unit 150 located within transceiverdevice 106 enables the position of transceiver device 106, and thereforethe position of patient 104, to be determined when necessary. Finally, aprocessor 152 located within transceiver device 106 exchangesinformation with each of devices 130-150, controls therapy associatedwith implantable medical device 102, controls transmission of databetween implantable medical device 102 and a remote location, such asdata storage unit 114 or a health care provider 116, provides real timedata that can be transmitted from patient 104 to the remote location,including a physician for example, closes a loop between multipleimplantable devices, and provides processing power external toimplantable medical device 102.

FIG. 3 is a schematic diagram of multi-directional data transmissionusing a transceiver device of the implantable medical device system ofFIG. 1. As illustrated in FIG. 3, according to multi-directional dataflow transmission of the present invention, an implantable medicaldevice 202, such as the Medtronic Inc. Chronicle IHM with medium rangetelemetry, for example, exchanges data with a transceiver device 206along a link 208 between implantable medical device 202 and atransceiver 238. Transceiver device 206 includes a pager type device,for example, positioned within close proximity to, or worn on a belt ofthe patient, or a band-aid, wristwatch, or pendant type devicepositioned within close proximity of the patient. Link 208 is a 3 Mhzbody wave telemetry link, for example.

An external reference sensor 214 senses a parameter external to thepatient, such as barometric pressure, for example. It is understoodthat, while sensor 214 is described in FIG. 3 as being a barometricpressure sensor, according to the present invention, sensor 214 couldsense any parameter external to the patient, such as temperature,position of the patients body, patient posture activity, and so forth.Transceiver device 206 exchanges information with a communication device212 along a wireless link 210 between a transceiver 239 of transceiverdevice 206 and a transceiver 217 located within communication device212. Link 210 is, for example, a 433 MHz radio frequency (RF) linkhaving a range of approximately 10 to 30 meters. Communication device212, which according to the present invention includes a base station, amonitor, a programmer or similar device, in turn exchanges informationwith a remote location, such as data storage unit 114 or a health careprovider 116 (FIG. 1) through a modem 218 and the Internet 120.

A user interface 242 is similar to interface 142 of FIG. 2, and includesan LCD, audible tones and input buttons to enable the patient to inputinformation within transceiver device 206 at any time, so that thepresent invention provides the patient with an increased level ofcontrol over their health and/or therapy. For example, according to thepresent invention, during an initial visit, a physician may instruct thepatient to ingest a certain drug if the patient's heart rate reaches acertain level or if the patient's blood pressure reaches a certain levelso that once the patient's heart rate or blood pressure is subsequentlydisplayed on LCD of interface 242 as being above the prescribed level,the patient is able to act accordingly on their own.

In addition, according to the present invention, once the heart rate orblood pressure reaches the prescribed level, an audible alarm soundsfrom interface 242 to inform the patient of the status of the parameter.Likewise, according to the present invention, information andinstructions can be communicated from the remote location to the patientthrough transceiver device 206 and communication device 212. Forexample, the physician at remote location 116 (FIG. 1) transmitsreminders or requests for the patient to visit the physician, directionsto remote location 116, and so forth, or manual or automated messagesare transmitted from the physician, which are displayed to the patientat user interface 242, or transmitted to the patient using audible tonesof interface 242. Battery levels, drug levels of drug pumps, andinformation regarding other type of therapies that the patient iscurrently on are also displayed at interface 242. In addition,medication reminders, which are displayed or audibly transmitted atinterface 242, are changed or updated at remote location 114 and 116, sothat when, as a result of data remotely received and conversations heldbetween the physician and the patient, a need to change medicationlevels is identified, the physician is able to download the changedirectly within transceiver device 206 and the reminder schedule wouldbe updated.

In addition, transceiver device 206 of the present invention enables thepatient, during a heart palpitation, for example, or other such event,to activate an input at interface 242 to store detailed therapy statusor physiologic signals regarding the event. Once informed of the event,transceiver device 206 triggers implantable device 202 to change from anormal state, in which implantable medical device 202 gathers data at aslow rate, or not at all, and performs a relatively high amount ofaveraging, to an increased state in which the amount and resolution ofdata is increased, so that a higher resolution of data can be obtainedand stored in transceiver device 206, concurrent with the onset of theevent, which can then be utilized in future diagnosis by the physician.

In addition, as illustrated in FIG. 3, microcontroller 252 oftransceiver device 206 receives and correlates raw pressure datareceived from sensor 214 to atmospheric pressure and determines, usingthe correlated data and a predetermined algorithm, whether drug dosagesshould be increased or decreased or whether a closed loop drug or othertherapy (electrical pacing, etc.) should take place. This determinationis then transmitted along link 208 to implantable medical device 202 orto remote location 114 and 116 (FIG. 1), which responds accordingly. Forexample, in a situation where implantable medical device 202 is a drugdelivery device, implantable medical device 202 adjusts dosage amountsaccordingly, or where an implantable medical device 202 is animplantable cardiac pacemaker, implantable medical device 202 increasesthe pacing rate of the patient either automatically, or in response toinput received from a physician located at a remote location, such ashealth care provider 116, through communication device 212 andtransceiver device 206.

FIG. 4 is a schematic diagram of a user interface of a transceiverdevice of the implantable medical device system of FIG. 1. Asillustrated in FIGS. 3 and 4, interface 242 of the present inventionincludes a patient physiologic parameter portion 260 that displaysphysiologic data of the patient, such the patient's heart rate, bloodpressure, and so forth, and a daily activity diary portion 262 thatenables the patient to enter activities such as eating activity,sleeping activity, exercise activity, restroom visits, and so forth. Amedication reminder portion 264 uses clock 148 (FIG. 2) to displaymedication reminders, or displays reminders in response to a requestreceived by transceiver device 206 from implantable medical device 202,and/or in response to data processed by implantable medical device 202and transceiver device 206. An event storage portion 266 storesphysiologic signals associated with the patient, processes signals,acquires the high resolution signal activity, and so forth, while a sendmessage portion 268 stores messages transmitted between the remotelocation 116 and transceiver device 206 and/or the patient, such as adata snap shot, text messages from the physician, an event trigger, suchas a tachycardia or bradycardia event, and so forth. An implantablemedical device status portion 270 adjusts and/displays battery status,therapy status, and device settings, while a receive message portion 272stores messages transmitted between remote location 114 and transceiverdevice 206 and/or the patient, such as automated information thatadjusts parameters or output of implantable medical device 202, ormanual information input directly at transceiver device 206. Asillustrated in FIGS. 3 and 4, in a low power standby mode 274,transceiver device 206 powers circuits that are not required, such asthose associated with portions 260-272 of interface 242. While instandby mode 274, transceiver device 206 periodically “listens” forsignals from either implantable medical device 202 or communicationdevice 212 to transition from standby mode 274 to an active mode.

FIG. 5 is a schematic diagram of remote processing of an implantablemedical device according to the present invention. As illustrated inFIGS. 1, 2, 4 and 5, the present invention enables information externalto the patient, such as barometric pressure, temperature, patient bodyposition and patient posture to be sensed through sensor 122.Transceiver device 106 performs calculations based on the externalinformation from sensor 122, and/or additional information fromimplantable medical device 102 stored over a storage interval, such asdiastolic, systolic and other parameters. The results of thecalculations are then stored in transceiver device 106 or transmitted toimplantable medical device 102 along link 108. As a result, the presentinvention enables data from both implantable medical device 102 andtransceiver device 106 to be used to trigger high resolution storage oralarms based on hemodynamic parameters.

According to the present invention, an audible alarm from user interface142 alerts patient 104 of hemodynamic parameters that are outsidepredetermined limits, and reasons or explanations for the alarm areprovided at the display of interface 142, along with suggestions forreturning the parameters back to acceptable levels through drug or dietadjustments, for example. Alternatively, the present invention enablesdata from status portion 270 of transceiver device 106 to be accessed bypatient 104 and described to a physician or caretaker in conversationsduring adverse events. Furthermore, if more than one device is implantedwithin patient 104, such as implantable medical devices 102 and 132,data obtained by transceiver device 106 based on information receivedfrom implantable medical device 102 is used as feedback controlinformation for implantable medical device 132. Implantable medicaldevice 132 includes implanted or external drug pumps, for example, orother such device.

Transceiver device 106 accesses external information from sensor 122 toprovide implantable medical device 102 directly with information forimproved operation and/or additional functions. For example, theaddition of the barometric pressure offset improves internal measuredphysiologic pressure resolution, and enables implantable medical device102 to calculate real diastolic and systolic pressures which could thenbe used to determine pacing and drug therapies, while diagnosticinformation such as external heart rate variability measurements assistin guiding the pacing and drug therapies. In the addition, transceiverdevice accesses external information from sensor 122 for use incalculations relating to operation functions of implantable medicaldevice 102, transmitting the results of the calculation to implantablemedical device 102 or communication device 106, which then respondaccordingly, or displays information or transmits an alarm to patientthrough interface 142.

Transceiver device 106 of the present invention also enables patient 104to input information regarding the status of patient 104 that wouldassist one or both devices 102 and 106. For example, patient 106 informstransceiver device 106 when going to sleep, of measured body weight,when feeling ill or pre-syncopal, or when a syncopal episode has justtaken place. Based on this patient input, transceiver device 106 eitherstores the information internally for later diagnostic use withimplantable medical device 102, provides the information directly toimplantable medical device 102 or to communication device 106, orperforms a calculation using the patient input. Upon receipt,implantable medical device 102 then utilizes the patient input toperform calculations, to change a therapy, or to deliver a therapy. Forexample, according to the present invention, implantable medical device102 increases a pacing rate as a result of information input by thepatient at transceiver device 106.

Alternately, upon receiving information from patient 104 or sensor 122,transceiver device 106 can change monitoring modes. For example,transceiver device 106 changes the resolution of storage to enable moredata to be recorded, or waits several minutes after receiving a messagefrom patient 104 that patient 104 is going to sleep to initiaterecording of baseline ECG or other patient parameters/signals. Likewise,a physician is able to remotely access the information input attransceiver device 106 by the patient through communication device 106.

The present invention enables system 100 to be automaticallyreprogrammed at a remote server, such as applications and data storageunit 114 (FIG. 1), or to be manually reprogrammed by patient 104, orremotely reprogrammed at remote location 116, or in a hospital,surgical, intensive care setting, by the physician, such as when thephysician determines that the status of the patient has changed,resulting in a need for implantable medical device 102 to bereprogrammed, or in response to determining that there is a need torestart system 100 after having retrieved frozen or other data.

In addition, transceiver device 106 is used for communication to a boxon a version of the same computer that handles programming via atelephonic link for programming during implant of device 102 and postimplant. Transceiver device 106 enables automatically captured data,such as ECG signal, heart rate, pressure signal, pressure parameters,and/or patient activity to be retrieved from implantable medical device102, increasing available memory space for storing additionalparameters, such as heart rate variability requiring DSP algorithmprocessing, or for more frequent measurements for higher resolution.Transceiver device 106 becomes aware of the need to offload theimplanted memory of stored data either on a periodic polling, or via anautomatic or semi-automatic link, or interactively by patient 104interactive control through interface 142. Transceiver device 106 eitherdirectly transmits the corresponding retrieved data to communicationdevice 112, acts as an intermediate storage medium transmitting theretrieved data to remote locations 114 and 116 for data viewing andanalysis, or performs calculations based on the retrieved data andtransmits the results of the calculations to implantable medical device102, to communication device 112, or to interface 142 for display or fortransmitting an alarm signal to the patient.

It will be appreciated that the present invention can be utilized tomonitor a patient and/or an implantable medical device implanted in apatient while in a hospital or intensive care setting by enablinginformation from the implantable medical device to be obtainedwirelessly. Furthermore, according to the present invention, uponreceipt of data from implantable medical device 102 and/or externalinformation from sensor 122, and after performing the calculations usingthe received data and/or external information, transceiver device 106either transmits the calculation results to implantable medical device102 and/or communication device 112, transmits instructions associatedwith the calculation results to implantable medical device 102, ortransmits a message or warning to the patient through interface 142. Inresponse to receiving the calculation results or instructions,implantable medical device 102 either performs a therapy or calculation,or stores the calculation results or instruction for future reference.In the alternative, upon receipt, transceiver device 106 merelytransmits the data and/or external information directly to communicationdevice 112.

According to the present invention, transceiver device 106 warns patient104 of device status issues through visual or audible feedback viastatus portion 270 of interface 142, and/or warns the physician orcaretaker via communication device 112 or at the remote location.Important device status issues could include, for example, low batteryand need for replacement, compromise in proper function of implantablemedical device 102 due to system or subsystem failure, excess currentamounts being utilized in a present mode of operation causing device 102to go to low battery prematurely, heart rhythm or cardiac status isindicative of a major problem already ongoing or imminent, and so forth.

Finally, transceiver device 106 also incorporates other useful ancillaryfeatures, such as being a standard time-piece, reminding patient 104,either visually, audibly or both to take medicines, or of activityrestrictions related to activities that the physician has instructedpatient 104 not to engage in.

FIG. 6 is a schematic diagram of multi-directional data transmissionusing a transceiver device of the implantable medical device system ofFIG. 1. As illustrated in FIG. 6, according to multi-directional dataflow transmission of the present invention, an implantable medicaldevice 302, such as the Medtronic Inc. Chronicle implantable hemodynamicmonitor (IHM) for cardiac heart failure with a medium range telemetrylink, for example, exchanges data with a transceiver device 306 along alink 308 between implantable medical device 302 and a transceiver 338.Transceiver device 306 includes a pager type device, for example,positioned within close proximity to, or worn on a belt of the patient,or a band-aid, wristwatch, or pendant type device positioned withinclose proximity of the patient, and so forth. Link 308 is a 3 Mhz bodywave telemetry link, for example.

An external reference sensor 314 senses a parameter external to thepatient, such as barometric pressure, and provides the externalparameter to a microcontroller 352 of transceiver device 306 along aserial connection 353. It is understood that, while sensor 314 isdescribed in FIG. 3 as being a barometric pressure sensor, according tothe present invention, sensor 314 could sense any parameter external tothe patient, such as, for example, temperature, position of the patientsbody, patient posture activity, and so forth.

Transceiver device 306 exchanges information with a communication device312 along a wireless link 310 between a transceiver 339 of transceiverdevice 306 and a transceiver 317 located within communication device312. Wireless link 310 is, for example, a 433 MHz radio frequency (RF)link having a range of approximately 30 to 70 meters. Communicationdevice 312, which includes a base station, a monitor, a physicianprogrammer, or other similar device, in turn exchanges information witha remote location, such as data storage unit 114 or health care provider116 (FIG. 1) through a modem type device 318. Microcontroller 352 oftransceiver device 306 is coupled, when necessary, such as during setupby a physician or nurse or during download of data, along a serial port355 to a computer device 357, such as a laptop computer, palm pilot, orsimilar device having additional processing power, memory/data storage,and user interface.

According to the present invention, microprocessor 352 stores data andperforms calculations based on information received from implantablemedical device 302 or sensor 314, or both. For example, microprocessor352 receives raw pressure data from sensor 314 and correlatesatmospheric pressure, for example, to determine, using the correlateddata and a predetermined algorithm, whether drug dosages should beincreased or decreased, and transmits the information to implantablemedical device 302, which, in the case where implantable medical device302 is a drug delivery device, adjusts dosage amounts accordingly. Inaddition, microprocessor 352 transmits data to computer device 357 foruse during set up, manufacture testing, and design debug procedures ofimplantable medical device 302, or for reference by the patient and/orphysician.

In addition, according to the present invention, new therapy algorithms,or new enabling therapy features, can be remotely downloaded to theimplantable medical device as they become available. Furthermore, thetransceiver device can contain algorithms for various purposes, such asalgorithms for altering control of the implantable medical device, foralarms to the patient based on data received from the implantablemedical device, and so forth, which can be downloaded or alteredremotely using the implantable medical device system of the presentinvention.

FIG. 7 is a schematic diagram of multi-directional data transmissionusing a transceiver device in the implantable medical device system ofFIG. 1. According to a preferred embodiment of the present invention, atransceiver device 406 is coupled to an implantable medical device 402along a link 408, such as a short range, low power telemetry link.Transceiver device 406 includes a band-aid type device, or peripheralmemory patch, such as the peripheral memory patch describe in U.S. Pat.No. 6,200,265 issued to Walsh et al., and hereby incorporated herein byreference in its entirety. An external reference sensor 414 oftransceiver device 406 is coupled along a port 411 to enable sensing ofparameters by sensor 414 external to the patient, such as barometricpressure for example. In addition, external reference sensor 415 iscoupled to the skin of the patient through a connector 419 to enabletransceiver device 406 to sense other external, physiological orenvironmental parameters, such as temperature, physical activity, and soforth. Surface ECG patches 421 are also coupled to the patient's skinthrough a connector 423 to enable transceiver device 406 to collectinformation for forming an electrocardiogram (ECG) of the patient. Skinconnectors 419 and 423 include gel patches, micro needles or any otherdevice for connecting to the patient's skin. Transceiver device 406exchanges information along link 408 with implantable medical device 402through an implantable medical device telemetry unit or transceiver 438and an antenna 441. Information is exchanged between a transceiver 439,such as a UHF transceiver, for example, and a long range source orcommunication device 412, which includes a monitor or physicianprogrammer, for example, along a long range telemetry link 410. Finally,a rechargeable or replaceable battery 446 is positioned provides energyto power transceiver device 406.

As illustrated in FIG. 7, a microcontroller 452 receives and stores ormanipulates information from sensors 414 and 415, patches 421 andtransceivers 438 and 439, and transmits received, stored, or manipulateddata to implantable medical device 402 and/or long range source 412 asdescribed above. For example, transceiver device 406 receives a signalfrom patches 421 and provides ECG signals corresponding to the patientto long-range source 412 for reference by a physician or the patient.Barometric data from sensor 414 provides a barometric reference forcalibrating an implanted cardiac pressure sensor, which could then beutilized for real-time therapy decisions.

FIG. 8 is a schematic diagram of multi-directional data transmissionusing a transceiver device in the implantable medical device system ofFIG. 1. As illustrated in FIG. 8, an implantable medical device system500 according to the present invention is similar to those previouslydescribed above, and includes an implanted medical device 502 implantedwithin a patient 504, and a transceiver device 506, such as a pager,band-aid, wristwatch or pendant type device positioned within closeproximity to implantable medical device 502 to be bi-directionallycoupled with implantable medical device 502 along a link 508. Inaddition, transceiver device 506 is coupled along a link 510 to acommunication device 512, such as a base station, monitor, or physicianprogrammer, for example, which in turn is coupled to the Internet 520and can thus be accessed at a remote location (not shown). Transceiverdevice 506 utilizes disposable (one-time use), replaceable, orrechargeable batteries (not shown).

According to a preferred embodiment of the present invention,transceiver device 506 includes a converter unit 501 for convertingbetween various different implantable medical device telemetry formats,each telemetry format having one or more unique features, such ascarrier frequency, modulation method, and/or data protocol. In this way,transceiver device 506 functions as a telemetry repeater of sorts,enabling transmission of data between implantable medical device 502 andtransceiver device 506 in multiple telemetry formats. For example, priorto transmitting the data to communication device 512, converter unit 501converts one of a telemetry range, carrier frequency, modulation method,and/or data protocol associated with information received fromimplantable medical device 502 to a corresponding telemetry range,carrier frequency, modulation method, and/or data protocol associatedwith communication device 512. In the same way, prior to transmittingdata to implantable medical device 502, converter unit 501 converts oneof a telemetry range, carrier frequency, modulation method, and/or dataprotocol associated with information received from communication device502 to a corresponding telemetry range, carrier frequency, modulationmethod, and/or data protocol associated with implantable medical device502. As a result, the present invention eliminates the need fortelemetry cables between communication device 512 and transceiver device506 so that patient 504 is free to go about daily activities while alarge data file is uploaded, or during programming or testing ofimplantable medical device 502. In addition, by eliminating the need fora hard wire connection between transceiver device 506 and communicationdevice 512, the present invention enables transceiver device 506 to moreeasily be entered within a sterile field during an implant procedure,for example, and enables wireless bedside monitoring in a hospital orintensive care setting.

Converter unit 502 periodically, or at certain physiological or otherevents, gathers data from implantable medical device 502 and transmitsthe gathered data or commands to second implantable medical device 132(FIG. 2). Transceiver device 506 also includes a memory 503 for storinginformation regarding implantable medical device 502, or conditions ofpatient 504 over time, so that patient 504 would activate transceiverdevice 506 prior to a follow-up visit and interrogate data to be turnedinto the physician or health care provider. For example, transceiverdevice 506 would be turned over to the health care provider and readinto the physician's programmer, via a PCMCIA or serial interface, orcould also reach the physician via a remote Internet connection. Forsurgical procedures, a short range implantable medical device telemetryis converted by converter unit 501 to a longer range implantable medicaldevice telemetry, such as a UHF link, for example, enabling thephysician programmer to be kept outside the sterile field. In this way,converter unit 501 allows a physician programmer to communicate withimplantable medical devices 506 and 132, for example, by enabling aphysician programmer related to one implantable medical device tocommunicate with a second implantable medical device different from thefirst device, removing the cost and complexity from a specificprogrammer or having to utilize separate programmers, while providingthe physician the ability to communicate with multiple implantablemedical devices (telemetry types) in an emergency room setting or in arural clinic, and to store information from a broad range of devices.

It is understood that while the communication device of the presentinvention has been described above as being base station, a monitor, aphysician programmer, or other similar device, communication device alsoincludes an Internet device, with or without user controls, thattransmits data remotely, such as to a physician programmer at a remotelocation, or to an Internet web page.

The preceding specific embodiments are illustrative of the practice ofthe invention. It is to be understood, therefore, that other expedientsknown to those of skill in the art or disclosed herein may be employed.In the following claims, means-plus-function clauses are intended tocover the structures described herein as performing the recited functionand not only structural equivalents but also equivalent structures. Forexample, although a nail and a screw may not be structural equivalentsin that a nail employs a cylindrical surface to secure wooden partstogether, whereas a screw employs a helical surface, in the environmentof fastening wooden parts, a nail and a screw are equivalent structures.It is therefore to be understood, that within the scope of the appendedclaims, the invention may be practiced otherwise than as specificallydescribed without actually departing from the spirit and scope of thepresent invention.

What is claimed is:
 1. An implantable medical device system, comprising:an implantable medical device for implantation within a patient, theimplantable medical device monitoring physiologic conditions of thepatient, and/or delivering a therapy in response to the physiologicconditions; a transceiver device, coupled to the implantable medicaldevice along a wireless link, exchanging data with the patient, betweenthe patient and the implantable medical device, and between a remotelocation and the implantable medical device; and a communication device,coupled to the transceiver device along a wireless link, exchanging datawith the transceiver device, with the implantable medical device throughthe transceiver device, and between the transceiver device and theremote location, wherein the implantable medical device system enablesbi-directional data transfer between the patient, the implantablemedical device, the transceiver device, the communication device, andthe remote location, wherein the transceiver device triggers theimplantable medical device to change from a normal state, in whichimplantable medical device gathers data at a first rate and performs arelatively high amount of averaging, to a second state in which theamount and resolution of data is increased so that an increasedresolution of data is obtained and stored in transceiver device inresponse to an input to the transceiver by the patient.
 2. Theimplantable medical device system of claim 1, the system furthercomprising a converter unit converting transmission of the data betweenthe implantable medical device, the transceiver device, and thecommunication device from a first telemetry format to a second telemetryformat.
 3. The implantable medical device system of claim 1, furthercomprising a direct interface coupling the transceiver device to anexternal device to enable direct downloading of the data andconfiguration/setup information to the external device, and connectionto user interface devices.
 4. The implantable medical device system ofclaim 1, wherein the transceiver device includes one of a pager typedevice, a band-aid, a wristwatch, and a pendant type device.
 5. Theimplantable medical device system of claim 1, further comprising anexternal reference sensor sensing a parameter external to the patient,the transceiver device receiving the sensed parameter from the externalreference sensor and/or receiving data from the implantable medicaldevice, wherein the transceiver device either directly transmits thesensed parameter and/or the data received from the implantable medicaldevice to the communication device, stores the sensed parameter and/orthe data received from the implantable medical device for subsequenttransmission to the remote location, performs calculations based on thesensed parameter and/or the data received from the implantable medicaldevice and transmits results of the calculations to the implantablemedical device or the communication device, or transmits a display or analarm signal corresponding to results of the calculation.
 6. Theimplantable medical device system of claim 1, further comprising a userinterface enabling information to be exchanged between the transceiverdevice and the patient, between the implantable medical device and thepatient through the transceiver device, and between the patient and theremote location.
 7. The implantable medical device system of claim 1,wherein data received by transceiver device is used as feedback controlinformation for a second implantable medical device for implantationwithin the patient.
 8. The implantable medical device system of claim 1,further comprising a removable memory storing information receiveddirectly from the transceiver device and received from the implantablemedical device through the transceiver device.
 9. The implantablemedical device system of claim 1, wherein the communication device isone of a base station, a monitor, a physician programmer, and aninternet device.
 10. The implantable medical device system of claim 1,wherein the system transmits a warning in response to status issuescorresponding to the implantable medical device through one of thetransceiver device, the communication device, and the remote location.11. The implantable medical device system of claim 1, wherein thetransceiver device reminds the patient to take medications, and/orreminds the patient of activity restrictions.
 12. The implantablemedical device system of claim 1, wherein the implantable medical devicesystem is reprogrammed directly by the patient or remotely at one of theremote location and the communication device.
 13. An implantable medicaldevice system, comprising: an implantable medical device forimplantation within a patient, the implantable medical device monitoringphysiologic conditions of the patient, and/or delivering a therapy inresponse to the physiological conditions; a transceiver device, coupledto the implantable medical device along a wireless link, exchanging datawith the patient, between the patient and the implantable medicaldevice, and between a remote location and the implantable medicaldevice; communication device, coupled to the transceiver device along awireless link, exchanging data with the transceiver device, with theimplantable medical device through the transceiver device, and betweenthe transceiver device and the remote location, wherein the implantablemedical device system enables bi-directional data transfer between thepatient, the implantable medical device, the transceiver device, thecommunication device, and the remote location; and a user inferfaceenabling information to be exchanged between the transceiver device andthe patient, between the implantable medical device and the patientthrough the transceiver device, and between the patient and the remotelocation, wherein the user interface comprises: a patient physiologicparameter portion displaying the physiologic conditions of the patient;a daily activity diary portion enabling the patient to input activitiesto the transceiver device; a medication reminder portion displayingmedication reminders in response to a request received from theimplantable medical device and in response to data processed by theimplantable medical device and the transceiver device; an event storageportion storing information, including the input activities andphysiologic signals associated with the patient, processing theinformation, and acquiring high resolution activity in response to theinformation; a send message portion storing messages transmitted betweenthe remote location and the transceiver device and/or the patient; astatus portion adjusting and displaying battery status, therapy status,and settings of the transceiver device; and a receive message portionreceiving messages transmitted between the remote location and thetransceiver device and/or the patient, the received messages includingone of automated information, adjusting parameter and output of theimplantable medical device, and manual information, input directly atthe transceiver device.
 14. A patient wearable transceiver deviceexchanging data with an implantable medical device for implantationwithin a patient and a communication device, comprising: means forreceiving information from the implantable medical device; means forexchanging data between the patient, the implantable medical device, thecommunication device, and a remote location; and means for processingthe data exchanged to enable bi-directional data transfer between thepatient, the implantable medical device, the transceiver device, and theremote location, wherein the transceiver device triggers the medicaldevice gathers data at a first rate and performs a relatively highamount of averaging, to a second state in which the amount andresolution of data is increased so that an increased resolution of datais obtained and stored in transceiver device in response to an input tothe transceiver by the patient.
 15. The device of claim 14, furthercomprising means for converting data exchanged between the implantablemedical device, the transceiver device, and the communication devicefrom a first telemetry format to a second telemetry format.
 16. Thedevice of claim 14, further comprising direct interface means couplingthe transceiver device to an external device to enable directdownloading of the data and configuration/Setup information to theexternal device, and connection to user interface devices.
 17. Thedevice of claim 14, wherein the transceiver device includes one of apager type device, a band-aid, a wristwatch, and a pendant type device.18. The device of claim 14, further comprising a sensing means forsensing a parameter external to the patient, the transceiver devicereceiving the sensed parameter from the sensing means and/or receivingdata from the implantable medical device, wherein the transceiver deviceeither directly transmits the sensed parameter and/or the data receivedfrom the implantable medical device to the communication device, storesthe sensed parameter and/or the data received from the implantablemedical device for subsequent transmission to the remote location,performs calculations based on the sensed parameter and/or the datareceived from the implantable medical device and transmits results ofthe calculations to the Implantable medical device or the communicationdevice, or transmits a display or an alarm signal corresponding toresults of the calculation.
 19. The device of claim 14, furthercomprising a user interface for enabling information to be exchangedbetween the transceiver device and the patient, between the implantablemedical device and the patient through the transceiver device, andbetween the patient and the remote location.
 20. The device of claim 14,wherein data received by transceiver device is used as feedback controlinformation for a second implantable medical device for implantationwithin the patient.
 21. The device of claim 14, further comprising meansfor storing information received directly from the transceiver deviceand received from the implantable medical device through the transceiverdevice, the means for storing information being removable from thedevice.
 22. The device of claim 14, further comprising means fortransmitting a warning in response to status issues corresponding to theimplantable medical device through one of the transceiver device, thecommunication device, and the remote location.
 23. The device of claim14, further comprising means for reminding the patient to takemedications and/or of activity restrictions.
 24. A patient wearabletransceiver device exchanging data with an implantable medical devicefor implantation within a patient and a communication device,comprising: means for receiving information from the implantable medicaldevice; means for exchanging data between the patient, the implantablemedical device, the communication device, and a remote location; meansfor processing data exchange to enable bi-directional data transferbetween the patient, the implantable medical device, the transceiverdevice, and the remote location; and a user interface means for enablinginformation to be exchanged between the transceiver device and thepatient, between the implantable medical device and the patient throughthe transceiver device, and between the patient and the remote location,wherein the user interface means comprises: means for displaying thephysiologic conditions of the patient; means for enabling the patient toinput activities to the transceiver device; means for displayingmedication reminders in response to a request received from theimplantable medical device and in response to data processed by theimplantable medical device and the transceiver device; means for storinginformation, including the input activities and physiologic signalsassociated with the patient, processing the information, and acquiringhigh resolution activity in response to the information; means forstoring messages transmitted between the remote location and thetransceiver device and/or the patient; means for adjuring and displayingbattery status, therapy status, and settings of the transceiver device;and means for receiving messages transmitted between the remote locationand the transceiver device and/or the patient the received messagesincluding one of automated information, adjusting parameters and outputof the implantable medical device, and manual information, inputdirectly at the transceiver device.
 25. An implantable medical devicesystem, comprising: an implantable medical device for implantationwithin a patient, the implantable medical device monitoring physiologicconditions of the patient, and/or delivering a therapy in response tophysiologic conditions; a transceiver device, coupled to the implantablemedical device along a wireless link, exchanging data with the patient,between the patient and the implantable medical device, and between aremote location and the implantable medical device; a communicationdevice, coupled to the transceiver device along a, wireless link,exchanging data with the transceiver device and with the implantablemedical device through the transceiver device, and exchanging databetween the transceiver device and the remote location; a converter unitconverting transmission of the data between the implantable medicaldevice, the transceiver device, and the communication device from afirst telemetry format to a second telemetry format; a direct interfacecoupling the transceiver device to an external device to enable directdownloading of the data and configuration/Setup information to theexternal device, and connection to user interface devices; an externalreference sensor sensing a parameter external to the patient, thetransceiver device receiving the sensed parameter from the externalreference sensor and/or receiving data from the implantable medicaldevice; and a user interface enabling information to be exchangedbetween the transceiver device and the patient, between the implantablemedical device and the patient through the transceiver device, andbetween the patient and the remote location.
 26. The implantable medicaldevice system of claim 25, wherein the user interface enable informationto be exchanged between the patient and the communication device. 27.The implantable medical device system of claim 25, wherein thetransceiver device either directly transmits the sensed parameter and/orthe data received from the implantable medical device to thecommunication device, stores the sensed parameter and/or the datareceived from the implantable medical device for subsequent transmissionto the remote location, performs calculations based on the sensedparameter and/or the data received from the implantable medical deviceand transmits results of the calculations to the implantable medicaldevice or the communication device, or transmits a display or an alarmsignal corresponding to results of the calculation.
 28. The implantablemedical device system of claim 27, wherein the transceiver deviceincludes one of a pager type device, a band-aid, a wristwatch, and apendant type device.
 29. The implantable medical device system of claim28, wherein the user interface comprises: a patient physiologicparameter portion displaying the physiologic conditions of the patient;a daily activity diary portion enabling the patient to input activitiesto the transceiver device; a medication reminder portion displayingmedication reminders in response to a request received from theimplantable medical device and in response to data processed by theimplantable medical device and the transceiver device; an event storageportion storing information, including the input activities andphysiologic signals associated with the patient, processing theinformation, and acquiring high resolution activity in response to theinformation; a send message portion storing messages transmitted betweenthe remote location and the transceiver device and/or the patient; astatus portion adjusting and displaying battery status, therapy status,and settings of the transceiver device; and a receive message portionreceiving messages transmitted between the remote location and thetransceiver device and/or the patient, the received messages includingone of automated information, adjusting parameters and output of theimplantable medical device, and manual information, input directly atthe transceiver device.
 30. The implantable medical device system ofclaim 29, Wherein data received by transceiver device is used asfeedback control information for a second implantable medical device forimplantation within the patient.
 31. The implantable medical devicesystem of claim 30, further comprising a removable memory storinginformation received directly from the transceiver device and receivedfrom the implantable medical device through the transceiver device. 32.The implantable medical device system of claim 31, wherein thetransceiver device triggers the implantabie medical device to changefrom a normal state, in which implantable medical device gathers data ata first rate and performs a relatively high amount of averaging, to asecond state in which the amount and resolution of data is increased sothat an increased resolution of data is obtained and stored intransceiver device in response to an input to the transceiver by thepatient.
 33. The implantable medical device system of claim 32, whereinthe communication device is one of a base station, a monitor, aphysician programmer, and an Internet device.
 34. The implantablemedical device system of claim 33, wherein the system transmits awarning in response to status issues corresponding to the implantablemedical device through one of the transceiver device, the communicationdevice, and the remote location.
 35. The implantable medical devicesystem of claim 34, wherein the transceiver device reminds the patientto take medications, and/or reminds the patient of activityrestrictions.
 36. The implantable medical device system of claim 35,wherein the implantable medical device system is reprogrammed directlyby the patient or remotely at one of the remote location and thecommunication device.
 37. An implantable medical device system,comprising; an implantable medical device for implantation within apatient, the implantable medical device monitoring physiologicconditions of the patient, and/or delivering a therapy in response tothe physiologic conditions; a transceiver device, coupled to theimplantable medical device along a wireless link, exchanging data withthe patient, between the patient and the implantable medical device, andbetween a remote location and the implantable medical device; acommunication device, coupled to the transceiver device along a wirelesslink, exchanging data with the transceiver device, with the implantablemedical device through the transceiver device, and between thetransceiver device and the remote location, wherein the implantabiemedical device system enables bi-directional data transfer between thepatient, the implantable medical device, the transceiver device, thecommunication device, and the remote location; a direct interfacecoupling the transceiver device to an external device to enable directdownloading of the data and configuration/setup information to theexternal device, and connection to user interface devices; and anexternal reference sensor sensing a parameter external to the patient,the transceiver device receiving the sensed parameter from the externalreference sensor and/or receiving data from the implantable medicaldevice.